Covid vaccinations: risk-benefit analysis
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A worldwide vaccination campaign is taking place that far surpasses that of the Swine flu vaccinations of 2009, it's perhaps the greatest campaign ever. Who should get a Covid-19 vaccine? In fact, how safe are those vaccines? Experts disagree about these important questions and on hindsight not all of the 2009 vaccines were safe. I present here my attempt to weigh the risks of the new COVID-19 vaccines against each other and against the risk of choosing none. I hope that this post will be useful for some of those who have not yet made up their mind.
In January, after I heard the positive news about Pfizer's vaccine trial I skimmed through their report. I was disappointed to find that the contents in the separate supplementary information of their report didn't match well with their very positive summary statements (details here below). Usually two full years are spent on evaluation of new vaccines and also in this case the health of vaccine volunteers will be monitored for two years. I decided to wait half a year and then examine the available information; now that time has come.
Coincidentally, European countries have begun pushing for vaccinating children as well with those new vaccines, despite the extremely low risk from Covid-19 for them. In my estimation, vaccination is generally more dangerous for children than Covid-19.
My local government advises to make a personal risk-benefit assessment. I totally agree with that, there's an obvious argument to have a careful look at the data; however the necessary data is hard to find and difficult to interpret.
In February an alarming letter appeared in the BMJ medical journal, pointing out that in the USA almost 50x more suspect deaths per number of doses were reported upon Pfizer and Moderna vaccinations than upon flu vaccinations. See an illustration here. As those vaccines require two doses, that suggests that the risks of those vaccines could be two orders of magnitude higher than common flu vaccines.
Covid-19 vaccines such as those of Pfizer, Moderna, AstraZeneca, Sputnik and Janssen all instruct the body to produce identical or nearly identical copies of the SARS2 spike protein. That spike protein is a small part on the outside of the SARS2 virus. Recently, several articles found that the SARS2 spike protein causes much of the typical Covid-19 damage, see here, here and here.
Happily, the vaccine-produced spike proteins are supposed to stay attached to the cells that produce them and the spike protein in mRNA vaccines has been slightly modified to reduce activity. But still, the similarities between some reported vaccine side effects and COVID-19 raised suspicions that the spike protein may find its way through the whole body and not, as is claimed, only near the injection area. In fact, small concentrations of nano particles were found in other organs in mRNA animal studies, showing that the spike proteins will not only be produced near the injection site. Some of the vaccine may come in the blood stream, although most vaccine likely remains near the injection site - if the injection is correctly done. In an animal study, 1% of the injected nano particles were found in the spleen which is part of the lymphatic system. See an interesting discussion (not just the post but also the critical comments) here. And I wonder, could it be that vaccine is also transported through the body by the lymphatic system? The lymphatic system may then be able to distribute vaccine through the body including the brain. The lymphatic system in turn is connected with fine blood vessels. The nano particles were also found in increasing quantities in ovaries and bone marrow; listen to this discussion with Robert Malone, developer of mRNA vaccine technology. UPDATE: now hidden on YouTube - but archived here.
In a press release, doctors and scientists stressed that "common reactions to vaccination, including headache, nausea, blurred vision and vomiting are symptoms of CSVT, and should be assessed as such, immediately". CSVT or CVST stands for cerebral venous sinus thrombosis.
I could not help noticing that in the AstraZeneca trial four people suffered from intravertebral disc protrusions (zero in the "placebo" group, see the Supplement). Didn't anyone else notice this? I checked the UK Yellow Card data, they have very many back pain reports with AstraZeneca - much more than with Pfizer. So I searched further and found that, amazingly, vertebral disk protrusion can indeed be caused by spinal artery infarcts (text under fig.14)! It thus looks to me that the clotting risk was already indicated by the clinical study results; if so, AstraZeneca should not have been given emergency authorizations for general use.
Here below I discuss:
1. Risk estimation from Covid-19
2. Risk estimations from vaccines
3. Efficacy of vaccines against COVID-19
4. Altruistic benefits
and then finally
5. Comparative risk assessments of vaccines vs no vaccination
1. Risk estimation from Covid-19
The reason to get vaccinated is the reduced risk of severe disease from SARS-COV2 (Covid-19). The USA's CDC estimated the risk to die upon infection at around 0.5% for the age group 50-65 yr (much lower for younger and much higher for older age groups).
A more recent estimation by Imperial College arrived at similar values of around 0.45% for 50-60 y.o. and a mean infection fatality rate of around 0.5% for all age groups combined (less for countries with young infected people, higher for those with older people). That report has a refined risk per age estimation.
In slight disagreement, a review of several of such reports by the WHO put the median risk at around 0.25 ("The median infection fatality rate across all 51 locations was 0.27% (corrected 0.23%)"). Not long thereafter, the same author published an update in which the global Infection Fatality Rate (IFR) is put at 0.15%, however he still estimated 0.3 to 0.4% for Europe.
I will use the estimations by age group of Imperial college, corrected downwards. For example, IFR for 50-60 y.o. 0.3%, and for 25-35 y.o. ca. 0.03% or 300 per million. Note that those estimations have a great variability, they can easily be off by a factor two or more.
Many governments gave in case of infection a lousy wait-and-see advice. Based on the impressive results with safe vitamins and medicines (see my earlier blog posts), I estimate for those who protect themselves accordingly the risk of dying from Covid-19 after infection to be reduced by up to a factor 10 to well below 0.1% on average. Such a modified IFR is close to typical flu fatalities.
Depending on your personal situation and the pandemic evolution, the forward-looking SARS-COV2 infection risk for the coming 12 months may be around 5% and very likely not more than 10% (in some presentations this important factor is ignored!). For example with 10% infection risk we find for the 40-45 year group a non-vaccinated risk of dying from COVID of ca. 10% x 0.1% = 0.01% (100 per million), the healthy and the ones in poor health combined.
Instead of vaccination or early treatment there's also the alternative of taking prophylactics; the May 2021 review is here.
2. Risk estimations of vaccines (death and serious effects), short term / long-term
It's primarily the risk of dying that we try to forego with vaccination, and it becomes immediately clear that the clinical trials were insufficient for its current usage. For example the Pfizer/BioNTech vaccine was evaluated in clinical trials involving about 22,000 vaccinated people of various age groups; that was insufficient for detecting acceptable risks for young people.
Still Pfizer's Dec.31 published interim report did contain a few less-than-nice results, hidden in the "Supplementary Appendix". In the main article, after briefly characterizing typical adverse events (so-called "the safety profile"), Pfizer people claimed: "the incidence of serious adverse events was low and was similar in the vaccine and placebo groups." But in fact, over 20% of the Pfizer vaccine receivers reported an adverse event (only 5% in saline placebo). Further, there were nearly twice as many severe adverse events (typically leading to hospitalization) as in the placebo group: the test group had 101/21621 = 0.5% more severe events than placebo! For some reason only 4 serious adverse events were assessed as "related" to the vaccine.
A YouTuber (Dr.Mobeen) unwittingly showed relatively high suspect Covid hospitalizations among healthy young people after Pfizer vaccinations in Israel. See also this short video overview that shows how noticeable this effect was in many countries. That and other data was analyzed in more detail by Yativ and Seligmann:
"Our reanalyses of these data explain why during the massive vaccination project initiated mid-December 2020 during a confinement, daily new confirmed COVID-19 cases failed to decrease as they do during confinements, and, more importantly, why numbers of serious, critical and death cases increased during that period that covered at least one month. [..] Presumably, asymptomatic cases before vaccination, and those infected shortly after the 1st dose, tend to develop graver symptoms than those unvaccinated."
Even a healthy young man died from Covid after the first Pfizer dose. It may therefore not be a good idea to get vaccinated at the height of a pandemic wave (that may also increase the risk of creating SARS2 variants).
In Norway, 23 frail elderly died shortly after receiving Pfizer vaccine which led to a temporary pause. Norway experts ascribed the death of at least 10 frail elderly to the vaccine. Could that be due to for example a flare of hypertension? See this hospital report from Switzerland.
A considerable number of bad experiences with Moderna on nine hundred vaccinated people was presented in an open letter with the remark that "these vaccine induced side effects are going almost entirely unreported, by those responsible for the vaccine rollout."
Regretfully none of those references enabled me to put numbers on vaccination fatality rates. To my regret, I could not find one official overall vaccine risk estimation that I could base myself on. Finally I discovered a pre-print article that discussed the relative risks of blood clots due to Covid-19 vs AstraZeneca and mRNA vaccines. It's the only large, real-life study that I found with vaccinated and unvaccinated patients. Here's the original story; see also the comments under this article, including an email by Pfizer. Following that, the authors published a third draft in which they hid the data that I needed. Therefore I used data of their second draft as a calibration point for my estimations with the UK's Yellow Card system, as detailed in the annex which has the calculations and comparisons.
The USA's CDC is monitoring possible serious side effects: in one presentation I noticed on slide 21 "Pulmonary embolism (subset of VTE), 19 events, 0 expected; No statistical signal". Huh?! The EMA (Eudravigilance) seems to do a little better: "the signal is confirmed".
Israel served as a country-wide test for Pfizer's mRNA vaccine and I came across a rather alarming report about Israel's vaccinations by the non-governmental "People's Committee". Their estimation was much higher for Pfizer than my own first estimation based on the UK's Yellow Card system. However I did my own estimations based on their data and references and managed to arrive at a reasonably consistent set of estimations (see the annex). The annex also takes a look at weekly death statistics.
My educated guesses of the risk of dying from vaccination for an average person (not including Covid):
AstraZeneca ca. 45 deaths per million people (= 0.25 / 5800 of the clinical trial)
Pfizer ca. 15 deaths per million people (= 0.30 / 20'000 of the clinical trial)
Moderna ca. 20 deaths per million people (= 0.3 / 15'000 of the clinical trial)
Those estimations remain very approximate, they can easily be off by a factor two, up or down. Originally my estimations were a bit higher but as the clinical trials didn't report any suspect death, I corrected them down for consistency.
My focus is here on the Pfizer vaccine. Based on the Israel data I estimate due to the Pfizer vaccine ca. 10 dead per million among the 20-29 years age group, and ca. 20 dead per million among the 50-59 years age group. Pfizer also tested their vaccine on 1134 kids of 12-15 years without issues. From that we can expect less than 0.1% of 12-15 y.o. kids to have serious side effects. [Edit: Correction, there appears to be at least one serious case! See comments.] That's by far not enough in view of the extremely low Covid risk for that age group - but it sufficed for emergency use authorization for kids in the USA...
More side effects are reported with the Moderna vaccine (with also more blood clot issues) than with the Pfizer vaccine, perhaps due to higher dosage levels.
The mRNA vaccines encapsulate the mRNA in lipids such as PEG, and that may lead to allergic reactions on the short term. The future risks of autoimmune diseases, cancer etc. seem small, but of course we'll only know for sure some years from now. Similarly we don't know the effect on overall health and more or less protection against other viruses.
With both mRNA vaccines there are issues reported with menstruation, and the People's Committee registered also many reports on vaginal bleeding as well as heart inflammation (myocardial and pericarditis) in young people. Fittingly, Israel may consider the option to give only one dose to teens.
I find it probable that Janssen and Sputnik are comparable to AstraZeneca. The Sinovac vaccine is an interesting alternative as they use inactivated whole virus, it's the only traditional vaccine. However, what I heard about it suggests to me that it also has a lot of side effects and that it isn't very effective. Moreover it has aluminium as adjuvant, which still asks for some scrutiny in view of the probable link between aluminium and Altzheimer disease, see also here and here.
3. Efficacy of vaccines against COVID-19 (= protection against severe disease)
This consideration has been rather well reported and discussed in the media, so I will be short on this. Currently the MRNA vaccines protect around 90% against getting Covid, and even better against hospitalization; "viral vector" vaccines such as from AstraZeneca protect less well. Those widely announced efficacies are about symptomatic COVID patients as well as hospitalizations; the protection against infection may be much less good.
Further, AstraZeneca is ineffective with the South African variant, and perhaps all currently available vaccines are doing less well with the "delta" variant. There's a serious risk of an "escape" in which many or most vaccinated persons will find themselves back at square one.
4. Altruistic benefits: reduction in risk of transmission to others
While government ads encourage people to get vaccinated now so as to reduce the risk of infecting other people, there's also a demand for worldwide vaccine justice: preferably give it to countries that lack vaccines instead of giving it to young people who do not need it in rich countries. Consequently, such altruistic benefits are debatable at the moment.
According to one study, there was about 50% less transmission after 2 doses from infected health care workers compared with non-vaccinated; and according to another study, single-dose Covid patients transmitted the virus about 50% less than non-vaccinated patients. If we suppose that also the risk of infection is reduced by at least 50%, then we find that the overall transmission risk is likely reduced by at least 75%.
Internationally there's a push to vaccinate children, not just to reduce infection risk and reaching so-called herd immunity, but also in order to keep schools open. That raises big ethical questions. Should children be obliged to endanger their health in order to reduce the risk for the elderly, or even just out of practical considerations?
5. Risks/benefits or comparative risk assessments of vaccines versus no vaccination
In a recent article about the death of a radio presenter, the Dailymail put the kind of information that I'm after:
Presentation of benefits and harms according to Wintoncentre of university of Cambridge.
However that is for only one type of risk of AstraZeneca, and possibly based on incomplete reports. Another article referring to Wintoncentre similarly suggested that young people better not take AstraZeneca.
Professor Sucharit Bhakdi sent an open letter to the EMA about vaccine safety [Edit: I wrongly wrote that the following explanation was in that letter]. In a later interview he explained that already just the known risks of AstraZeneca [edit: for people under 60] are similar to experienced Covid-19 risks in Germany - listen to his explanation here. And in that same video interview, he put my attention to another revealing aspect of the Pfizer clinical trial, closely related to what I had noticed myself. In fact [correcting Bhakdi's recall from memory], severe Covid cases were 8 less with Pfizer than in the placebo group; but among the Pfizer vaccinated people, almost 100 more people suffered from severe adverse events than among those with saline placebo (no vaccine or Covid related deaths were reported). In that time period, Covid infection rates were quite low, but it's that type of real world comparisons that matter.
Finally, here follow a few estimations related to COVID-19. These estimations don't take into account potential later effects related to "long covid" or eventual belayed vaccine side effects such as auto-immune reactions, increased illness from infection, disabling effects or cancer, nor a possibly increased Covid risk during the vaccination period.
Assuming an estimated 10% infection risk during the coming year (and 0% infection risk with vaccination, which is too optimistic):
Case 1.
- an average person (that corresponds to 50-60 y.o. age group)
- who doesn't take extra vitamins and who plans not to take medicine if infected:
Risk to die from COVID-19: 300/million
Risk to die from Pfizer vaccine: 20/million
This may seem inconsistent with the observation here above in which Pfizer looks worse than Covid itself; however during the Pfizer clinical trial less than 1% of the placebo group was infected. Moreover, I noticed in the "Yellow Cards" system that even severe side effects with Pfizer tend to be rarely lethal (except, it seems, if one is very fragile, or inversely, if one has a very reactive immune system).
Case 2.
- a healthy, slim person of 50-60 y.o. (I will assume that it reduces the risk from COVID-19 and to a lesser degree the risk from the vaccine)
- who DOES take extra vitamin D and who will take medicine if infected (assume 90% less risk).
Risk to die from COVID-19: 300/3/10 /million = 10/million
Risk to die from Pfizer vaccine: 20/2 /million = 10/million
Case 3.
- an average person of 20-30 y.o.
- who doesn't take extra vitamins and who plans not to take anti viral medicine if infected.
Risk to die from COVID-19: 20/million
Risk to die from Pfizer vaccine: 10 /million
As the risk of AstraZeneca vaccine appears to be considerably higher than these estimations, they match well with the opinion of Norway's minister of health: "Since there are few people who die from covid-19 in Norway, the risk of dying after vaccination with the AstraZeneca vaccine would be higher than the risk of dying from the disease, particularly for younger people."
Overview:
20-30 y.o. | 50-60 y.o. | ||
---|---|---|---|
COVID-19 | Pfizer vaccine | COVID-19 | Pfizer vaccine |
20/million | 10/million | 300/million | 20/million |
20-30 y.o. | 50-60 y.o. | ||
---|---|---|---|
COVID-19 | Pfizer vaccine | COVID-19 | Pfizer vaccine |
60/million | 10/million | 1000/million | 40/million |
20-30 y.o. | 50-60 y.o. | ||
---|---|---|---|
COVID-19 | Pfizer vaccine | COVID-19 | Pfizer vaccine |
10/million | 10/million | 100/million | 10/million |
20-30 y.o. | 50-60 y.o. | ||
---|---|---|---|
COVID-19 | Pfizer vaccine | COVID-19 | Pfizer vaccine |
1/million | 10/million | 10/million | 10/million |
These are just my own rough estimates about the short term risks, without accounting for the fact that men generally suffer more from Covid-19 than women, but suffer less from corona vaccine side effects; and without accounting for possible future side effects from vaccines. Nevertheless it helped me with my choice. Was it helpful for you?
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